Manufacturing Associate - Cell Therapy

Manufacturing Associate - Cell Therapy

Location: Irvine, CA (Onsite)

Employment Type: Full-time, Exempt

AIVITA Biomedical is a fast‑growing biotechnology company advancing personalized vaccines for the prevention of infectious disease and treatment of cancer. Our autologous cell therapy platform, built on cutting‑edge immunology and stem cell science, is driving multiple clinical programs and innovative vaccine technologies. We operate in a dynamic, collaborative environment where every team member directly contributes to product quality, patient safety, and our mission to transform lives through science.

The Manufacturing Department is hiring a mid‑level Manufacturing Associate to support clinical cell therapy programs in a fast‑paced biotech environment. This is a hands‑on, execution‑focused role for someone with at least 2 years of relevant experience who wants to deepen cGMP manufacturing capability and grow with the company over time.

You will help manufacture patient‑specific and related cell‑based products, working with primary and established human cell cultures in a cGMP setting, and contribute to selected process improvements and development activities as programs evolve. The role offers broad exposure to clinical manufacturing, quality, and cross‑functional collaboration in a small‑company setting where the work directly supports patients and key business milestones.

• Execute cGMP manufacturing activities for cell therapy products according to approved SOPs and production schedules.
• Perform aseptic cell culture and associated processing steps on primary human cell cultures and patient biomaterial in a regulated laboratory environment.
• Handle patient‑derived materials from receipt through cell isolation, expansion, final product manufacturing, QC submissions, and preparation for shipment or release.
• Prepare media, reagents, QC submission samples, and support cryo‑inventory and material management.

• Complete batch records and other controlled documentation accurately, legibly, and in real time following good documentation practices.
• Monitor processes for deviations or atypical observations and promptly elevate issues through appropriate channels.
• Support sample submissions to QC and help maintain audit‑ready documentation and work areas.

• Participate in routine troubleshooting during manufacturing runs by documenting findings, contributing to root‑cause discussions, and helping test practical fixes.
• Assist with process improvements and development protocols that enhance robustness, efficiency, or scalability of manufacturing operations.

• Collaborate closely with Manufacturing, R&D, QA, QC, and other functions to meet clinical and operational timelines.
• Work primarily standard weekday hours, with flexibility for occasional early mornings, evenings, or weekends driven by patient specimen receipts and manufacturing demand.

• Bachelor’s degree in biology, biochemistry, biotechnology, biomedical science, or a closely related life‑science field, or equivalent practical experience.
• Minimum of 2 years of relevant hands‑on experience in cell culture, biologics manufacturing, cell therapy manufacturing, or a comparable biotech laboratory environment.
• Proven aseptic technique with mammalian cell culture; experience with primary human cells is strongly preferred.
• Experience working within cGMP or similarly regulated environments, including completing batch records or other controlled documentation.
• Strong attention to detail, organization, and follow‑through.
• Demonstrated ability to learn new protocols quickly and execute them consistently after training.
• Clear, professional written and verbal communication skills.
• Willingness to work an on‑site role with occasional schedule flexibility based on patient and program needs.

• Experience handling human clinical specimens such as tumor tissue, blood‑derived products or materials.
• Background in clinical‑stage cell therapy, regenerative medicine, or other human…